NCT02847078

Brief Summary

The purpose of the study is to investigate the effects of smart phone app on the secondary prevention for patients with coronary heart disease post percutaneous coronary intervention.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 28, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

September 20, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

May 25, 2022

Status Verified

April 1, 2016

Enrollment Period

6 months

First QC Date

July 13, 2016

Last Update Submit

May 19, 2022

Conditions

Coronary Disease

Keywords

Coronary Diseasepercutaneous coronary interventionsecondary preventionsmart phone app

Outcome Measures

Primary Outcomes (1)

  • Change in quality of life

    Seatt1e Angina Questionnaire

    Baseline and 1 and 6 months

Secondary Outcomes (7)

  • Change in medication compliance

    Baseline and 1 and 6 months

  • Change in systolic blood

    Baseline and 1 and 6 months

  • Change in diastolic blood pressure

    Baseline and 1 and 6 months

  • Changes in serum total cholesterol

    Baseline and 1 and 6 months

  • Changes in serum triglyceride

    Baseline and 1 and 6 months

  • +2 more secondary outcomes

Study Arms (2)

Smart phone app

EXPERIMENTAL

The app contains education materials for secondary prevention of coronary artery disease. So patients can access them very easily. The app pushes heath management recommendation information on the timeline after percutaneous coronary intervention, and also provides health care lecture to help patients to improve their secondary prevention. And online or telephone consultation ways are integrated into the App to provide convenience for patients to communicate with health care professionals.

Device: smart phone app

Control group

OTHER

Participants allocated to the control group will receive a booklet with general advice on secondary prevention of coronary artery disease.

Device: A guideline booklet

Interventions

smart phone appDEVICE

App for this study is provided with real time updating educational materials, reminder, and consultation for improving secondary prevention, and the related information is pushed to a patient in chronological order after his or her PCI operation.

Smart phone app
A guideline bookletDEVICE

A guideline booklet with general advice on secondary prevention of coronary artery disease.

Control group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • First diagnosis of coronary heart disease and received a PCI treatment.
  • Age 18-65 years.
  • Able and willing to provide written informed consent.

You may not qualify if:

  • Speech communication barriers.
  • Patients with a clear history of allergies to anti-platelet drugs.
  • Patients with a clear history of allergies to anti-platelet ᵦ-blockers.
  • Patients with a clear history of allergies to statin drugs.
  • Patients with a clear history of allergies to antihypertensive drugs.
  • Patients with a clear history of allergies to antidiabetic drugs.
  • Patients with serious heart failure(better than NYHA class II).
  • Patients with cerebral infarction or cerebral hemorrhage.
  • Patients with liver dysfunction (AST and ALT\> 2 times that of the reference value).
  • Patients with kidney dysfunction (creatinine clearance rate\< 60ml/min).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Bommer WJ. Coronary revascularization: then, now, future trends. Rev Cardiovasc Med. 2014;15(2):176-7. doi: 10.3909/ricm15-2CAACC. No abstract available.

    PMID: 25051135RESULT

  • White CJ. The future of interventional cardiology. Catheter Cardiovasc Interv. 2013 Jan 1;81(1):4-5. doi: 10.1002/ccd.24734. No abstract available.

    PMID: 23281080RESULT

  • Sim DS, Kim JH, Jeong MH. Differences in Clinical Outcomes Between Patients With ST-Elevation Versus Non-ST-Elevation Acute Myocardial Infarction in Korea. Korean Circ J. 2009 Aug;39(8):297-303. doi: 10.4070/kcj.2009.39.8.297. Epub 2009 Aug 27.

    PMID: 19949634RESULT

  • Pocock S, Bueno H, Licour M, Medina J, Zhang L, Annemans L, Danchin N, Huo Y, Van de Werf F. Predictors of one-year mortality at hospital discharge after acute coronary syndromes: A new risk score from the EPICOR (long-tErm follow uP of antithrombotic management patterns In acute CORonary syndrome patients) study. Eur Heart J Acute Cardiovasc Care. 2015 Dec;4(6):509-17. doi: 10.1177/2048872614554198. Epub 2014 Oct 9.

    PMID: 25301783RESULT

  • Goel K, Lennon RJ, Tilbury RT, Squires RW, Thomas RJ. Impact of cardiac rehabilitation on mortality and cardiovascular events after percutaneous coronary intervention in the community. Circulation. 2011 May 31;123(21):2344-52. doi: 10.1161/CIRCULATIONAHA.110.983536. Epub 2011 May 16.

    PMID: 21576654RESULT

  • Yusuf S, Hawken S, Ounpuu S, Dans T, Avezum A, Lanas F, McQueen M, Budaj A, Pais P, Varigos J, Lisheng L; INTERHEART Study Investigators. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-control study. Lancet. 2004 Sep 11-17;364(9438):937-52. doi: 10.1016/S0140-6736(04)17018-9.

    PMID: 15364185RESULT

  • Heo J, Chun M, Lee KY, Oh YT, Noh OK, Park RW. Effects of a smartphone application on breast self-examination: a feasibility study. Healthc Inform Res. 2013 Dec;19(4):250-60. doi: 10.4258/hir.2013.19.4.250. Epub 2013 Dec 31.

    PMID: 24523989RESULT

  • Svetkey LP, Batch BC, Lin PH, Intille SS, Corsino L, Tyson CC, Bosworth HB, Grambow SC, Voils C, Loria C, Gallis JA, Schwager J, Bennett GG. Cell phone intervention for you (CITY): A randomized, controlled trial of behavioral weight loss intervention for young adults using mobile technology. Obesity (Silver Spring). 2015 Nov;23(11):2133-41. doi: 10.1002/oby.21226.

    PMID: 26530929RESULT

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Jingwen Hu, Master

    First Affiliated Hospital Xi'an Jiaotong University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2016

First Posted

July 28, 2016

Study Start

September 20, 2016

Primary Completion

April 1, 2017

Study Completion

May 1, 2017

Last Updated

May 25, 2022

Record last verified: 2016-04